Stress urinary incontinence (SUI), defined as involuntary leakage of urine from the bladder accompanying physical activity which causes increased intraabdominal pressure, is a common medical problem currently affecting as many as 25 to 50 percent of women in the U.S. This condition is twice as common in women as in men. The absence of a standardized epidemiologic definition of SUI makes it difficult to establish the true prevalence of the disorder. It is known that the prevalence increases with age. Likely these estimates are underreported due to the fact that women are often too ashamed or embarrassed to discuss this issue, even with their health care providers. Urinary incontinence is associated with substantial costs.⋅ In addition to high economic costs, urinary incontinence results in medical and psychological morbidity and diminished quality of life. The economic costs are substantial, currently accounting for over $20 billion per year in the U.S., with a majority (50-75%) attributed to resources used for incontinence management or routine care⋅ such as absorbent pads, protection, and laundry. According to data collected in the SISTEr trial which included health-related quality of life assessments, women reported the impact of SUI on health-related quality of life to be similar to the impact of other chronic and debilitating medical conditions such as stroke, cancer, diabetes, back pain and dementia. Women in this trial spent a median of $500 annually out of pocket for urinary incontinence management which represented almost one percent of their annual household income, which is comparable to the mean annual out-of-pocket spending on prescription drugs for workers with health insurance benefits.
Currently, there are initial intervention options for the management of SUI. A common option is the use of absorbent pads and diapers. Behavioral training including bladder training, pelvic floor muscle exercises and electric stimulation can also be used. While these techniques can sometimes be helpful in strengthening the pelvic floor muscles in some individuals, this process can take a significant amount of dedication, time, and money.
Urethral plugs which are designed to completely occlude the urethra can be very uncomfortable, and because they are inserted directly into the urethra, carry a significant risk of infection.
Intravaginal indwelling pessaries require a prescription, an appointment with a healthcare provider for fitting, and regular doctor visits for removal/cleaning/reinsertion.
U.S. Pat. No. 7,771,344 discloses an intravaginal device for urinary incontinence that uses extending posts or arms that engage the vaginal wall to secure the device and establish a cradle to provide the intended support to the urethra.
U.S. Patent Application Publication 2009/0095304 discloses an intra-vaginal pessary device that is an approximately oval, non-absorbent device with an embedded pull string. The pessary is described as either a solid or as being hollowed out for the passage of fluids.
U.S. Pat. No. 6,770,025 discloses a molar shaped vaginal incontinence device that includes a hollowed out passage and an enlarged distal end that can collapse on itself during removal.
U.S. Pat. No. 8,926,493 discloses a non-expandable pessary device adapted to provide pressure on the user, s urethra with a pressure region of a larger diameter and a flexile region of smaller diameter and less resistant than the pressure region. This pessary has a hollow region.
Additionally, over 200 different surgical approaches have been described to treat SUI f these can result in potential complications and significant risks associated with surgery.